FEMA GRAS assessment of natural flavor complexes: Lemongrass oil, chamomile oils, citronella oil and related flavoring ingredients. (May 2023)

• Record Type: Journal Article
• Authors: Rosol, Thomas J.; Cohen, Samuel M.; Eisenbrand, Gerhard; Fukushima, Shoji; Gooderham, Nigel J.; Guengerich, F. Peter; Hecht, Stephen S.; Rietjens, Ivonne M.C.M.; Davidsen, Jeanne M.; Harman, Christie L.; Kelly, Shannen; Ramanan, Danarubini; Taylor, Sean V.
• Is Part Of: Food and chemical toxicology. Volume 175(2023)
• Publication Date: 2023-05
• Subjects: Essential oils -- Absolutes and extracts -- Primary alcohol -- aldehyde -- Acid and ester constituents -- Natural Flavor Complex -- GRAS -- Safety evaluation; ADI Acceptable daily intake -- ALT Alanine aminotransferase -- ALP Alkaline phosphatase -- CAC Codex Alimentarius Commission -- CBPI Cytokinesis-block proliferation index -- CF Correction factor -- CFR Code of Federal Regulations (USA) -- CHO Chinese hamster ovary (cells) -- DTC Decision tree class -- ECHA European Chemicals Agency -- EFFA European Flavour Association -- EFSA European Food Safety Authority -- FCC Food Chemicals Codex -- FDA Food and Drug Administration -- FEMA Flavor and Extract Manufacturers Association -- FID Flame ionization detector -- GC-MS Gas chromatography-mass spectrometry -- GD Gestation day -- GLP Good laboratory practices -- GRAS Generally recognized as safe -- GST Glutathione S-transferase -- HPBL Human peripheral blood lymphocytes -- HRPT Hypoxanthine (guanine) phosphoribosyltransferase (assay) -- IFEAT International Federation of Essential Oils and Aroma Trades -- IOFI International Organization of the Flavor Industry -- JECFA Joint FAO/WHO Expert Committee on Food Additives -- JFFMA Japan Fragrance and Flavor Materials Association -- LOD Limit of detection -- MoS Margin of safety -- NFC Natural flavor complex -- NTP National Toxicology Program -- NOAEL No observed adverse effect level -- OECD Organization for Economic Co-Operation and Development -- OFAS Office of Food Additive Safety (FDA) -- PCE Polychromatic erythrocytes -- PCI Per capita intake -- PHA Phytohaemagglutinin -- PPD Postpartum day -- RBC Red blood cell -- SCE Sister chromatid exchange (assay) -- TD50 Dose giving a 50% tumor incidence -- TTC Threshold of toxicological concern -- WHO World Health Organization; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2023.113697
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: In 2015, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) initiated a program for the re-evaluation of the safety of over 250 natural flavor complexes (NFCs) used as flavor ingredients. This publication, eleventh in the series, evaluates the safety of NFCs characterized by primary alcohol, aldehyde, carboxylic acid, ester and lactone constituents derived from terpenoid biosynthetic pathways and/or lipid metabolism. The scientific-based evaluation procedure published in 2005 and updated in 2018 that relies on a complete constituent characterization of the NFC and organization of the constituents into congeneric groups. The safety of the NFCs is evaluated using the threshold of toxicological concern (TTC) concept in addition to data on estimated intake, metabolism and toxicology of members of the congeneric groups and for the NFC under evaluation. The scope of the safety evaluation does not include added use in dietary supplements or any products other than food. Twenty-three NFCs, derived from the Hibiscus, Melissa, Ricinus, Anthemis, Matricaria, Cymbopogon, Saussurea, Spartium, Pelargonium, Levisticum, Rosa, Santalum, Viola, Cryptocarya and Litsea genera were affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavor ingredients based on an evaluation of each NFC and the constituents and congeneric groups therein. Highlights: Safety evaluation of natural flavoring complexes. Evaluation used procedure developed by the FEMA Expert Panel for natural flavor complexes. FEMA GRAS status determined/affirmed for 23 natural flavor complexes.